Zinc as an adjunct treatment for reducing case fatality due to clinical severe infection in young infants: study protocol for a randomized controlled trial.

BACKGROUND: An estimated 2.7 of the 5.9 million deaths in children under 5 years of age occur in the neonatal period. Severe infections contribute to almost a quarter of these deaths. Mortality due to severe infections in developing country settings is substantial despite antibiotic therapy. Effective interventions that can be added to standard therapy for severe infections are required to reduce case fatality. METHODS/DESIGN: This is a double-blind randomized placebo-controlled parallel group superiority trial to investigate the effect of zinc administered orally as an adjunct to standard therapy to infants aged 3 days up to 2 months (59 days) hospitalized with clinical severe infection, that will be undertaken in seven hospitals in Delhi, India and Kathmandu, Nepal. In a 1:1 ratio, we will randomly assign young infants to receive 10 mg of elemental zinc or placebo orally in addition to the standard therapy for a total of 14 days. The primary outcomes hospital case fatality, which is death due to any cause and at any time after enrolment while hospitalized for the illness episode, and extended case fatality, which encompasses the period until 12 weeks after enrolment. DISCUSSION: A previous study showed a beneficial effect of zinc in reducing the risk of treatment failure, as well as a non-significant effect on case fatality. This study was not powered to detect an effect on case fatality, which this current study is. If the results are consistent with this earlier trial, we would have provided strong evidence for recommending zinc as an adjunct to standard therapy for clinical severe infection in young infants. TRIAL REGISTRATION: Universal Trial Number: U1111-1187-6479, Clinical Trials Registry - India: CTRI/2017/02/007966 : Registered on February 27, 2017.

A two-centre collaborative study on clinico-epidemiological profile of a recent outbreak of epidemic dropsy in New Delhi (India) with special emphasis on its cardiac manifestations in pediatric patients.

A hundred and six clinically diagnosed cases of epidemic dropsy, admitted in June to August 1998 to the P-III unit of RML Hospital and the Department of Pediatrics, Safdarjang Hospital, were studied. All of them consumed mustard oil contaminated with Argemona mexicana, confirmed by ferric chloride and nitric acid tests. No specific sex predilection was seen. No child was affected below the age of 3 years. Pedal edema and reddish hyperpigmentation were the most consistent findings (100 per cent). Frank cardiac failure was seen in only 24 (22.64 per cent), yet persistent tachycardia was alarmingly high (104/106, i.e. 98.4 per cent). Notably ECG showed prolonged Q-T interval in 24 children (22.64 per cent), unrelated to serum Ca2+ level in patients with congestive cardiac failure (CCF). Color Doppler echocardiography showed biventricular dilatation in all the 24 patients with CCF. Wide pulse pressure was recorded in two patients only. Mortality occurred in only two patients (1.89 per cent). Eye involvement was a late finding. All those who survived (i.e. 104/106) recovered completely, except two patients who were left with sarcoid-like changes of skin telangiectasia.